Kornimate/medical-research-clean huggingface dataset:
ovarian ageing in type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: in healthy women, early menopause is an event that is associated with the exacerbation of several risk factors of cardiovascular and skeletal disease. the occurrence of an early menopause may have even greater impact in women with type 1 diabetes mellitus (dm-1). a small number of studies has demonstrated that dm-1 patients experience cycle irregularity and menopause at a younger age compared to controls. in addition, initial studies have suggested that also in regular cycling dm-1 women a decreased ovarian reserve status for age is present. the explanation for this early decay in ovarian reserve in dm-1 patients remains unknown. next to auto immunity, vascular factors may be possible contributors to accelerated ovarian ageing in dm-1 patients. confirmation of more accelerated ovarian ageing in dm-1 women is urgently needed in view of the added risk factors outlined above. also, the mechanisms behind the advanced ovarian ageing, with focus on vascular factors, may shed new light on our understanding of the ovarian ageing process per se.


Eligibility criteria:
inclusion criteria: * patients: females diagnosed with type 1 diabetes mellitus * controls: healthy age-matched female controls exclusion criteria: * induced menopause: surgical (premenopausal hysterectomy and/or bilateral ovariectomy), chemo- or radiation therapy, ovarian surgery and irregular menstrual cycles.
pilot study evaluating the use of a new device for transanal irrigation in patient with bowel disorders

Conditions: Therapeutic Irrigation

Summary: the study descripted of efficacy of irypump®r set in term of success of the procedure at each irrigation


Eligibility criteria:
inclusion criteria: 1. patient is at least 18 years old, 2. patient having signed an informed consent 3. patient having neurologic or non neurologic bowel disorders, being initiated to tai and practicing tai with peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results. 4. patient practicing tai on the basis of 1 procedure/ week as a minimum or more frequently 5. patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver 6. patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) 7. patient agrees to test irypump® set r for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks. 8. patient covered by social security exclusion criteria: 1. patient with bowel obstruction 2. patient already participating in another clinical study or who have previously participated in this investigation, 3. pregnant or breast-feeding woman
apatinib in refractory colorectal cancer

Conditions: Colorectal Neoplasms

Summary: limited agents have been approved after standard first and second line treatment. regorafenib and trifluridine/tipiracil (tas-102) are still not approved in china.apatinib has shown significant efficacy in refractory advanced gastric cancer regarding pfs and os with controllable toxicity.this study is aimed to explore the efficacy,safety as well as predictive biomarker in advanced colorectal cancer failed to standard therapy in chinese population.


Eligibility criteria:
inclusion criteria: * histological or cytological documentation of adenocarcinoma of the colon or rectum. all other histological types are excluded. * subjects with metastatic colorectal cancer(crc) (stage iv). * subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan. * subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy. * subjects who have withdrawn from standard treatment due to unacceptable toxicity and precluding retreatment with the same agent prior to progression of disease will also be allowed. * prior treatment with bevacizumab and/or cetuximab will be allowed. * measurable disease according to response evaluation criteria in solid tumors (recist) criteria, version 1.1.is necessary. * eastern cooperative oncology group (ecog) performance status of 0-1. * life expectancy of at least 3 months. * adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol. * assigned informed consent. exclusion criteria: * previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[ta (non-invasive tumor), tis (carcinoma in situ) and t1 (tumor invades lamina propria)\]. * participants of other clinical trial within 4 weeks. * diseases which will impact the absorption of apatinib, eg. dysphagia, chronic diarrhea, bowl obstruction * hemorrhage events of ≥grade 3 within 4 weeks. * known central nervous system metastasis. * uncontrolled hypertension. (systolic blood pressure 140 mmhg or diastolic pressure 90 mmhg despite optimal medical management). unstable angina,congestive heart failure,myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy. * urine protein ≥++ and 24h urine protein more than 1.0g. * chronically green wound or bone fracture. * arterial or venous thrombotic or embolic events. * tumor invading important blood vessel with high risk of severe hemorrhage. * abnormal coagulation function. * thromboemboli events within 6 months.
drug use during sex and its impact on taking prep (pre-exposure prophylaxis) : consume

Conditions: Drug Dependence

Summary: this is a cross-sectional, single-center observational study conducted from october 2020 to march 2021 in ile de france at the infectious disease of chu bichat (prep and cegidd(free center for information, screening and diagnosis of infections by human immunodeficiency viruses, viral hepatitis and sexually transmitted infections) consultation). it concerns adult subjects of male or transgender sex, of msm (men having sex with men) or bi-sexual orientation. the data are collected by self-questionnaire evaluating the consumption of chemsex (drug use in a sexual context) over the last 12 months, the existence or not of addiction treatment, the history of stis (sexually transmitted infections) and adherence to prep (for subjects taking prep) during the last sexual intercourse (anrs questionnaire, used in the prevenir study).


Eligibility criteria:
inclusion criteria: * age\> 18 * male or transgender * msm or bi-sexual orientation * adult consultant at bichat hospital (cegidd or prep consultation) * adult with a smartphone (online self-questionnaire) exclusion criteria: * for the group "taking prep": adult taking prep for less than 3 months * refusal of participation

Keywords: chemsex prep
study of sildenafil in patient with heart failure.

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to determine if sildenafil (viagra) improves exercise tolerance.

patients will undergo an exercise stress test. one dose of sildenafil will then be given, followed by a one hour rest period. a repeat exercise stress test will then be repeated.

Eligibility criteria:
inclusion criteria: age 18 - 75 ejection fraction \<35% heart failure limited by fatigue and shortness of breath - exclusion criteria: inability to exercise. patients with shortness of breath while resting. patient requiring intravenous medication. patients taking the following medications: nitroglycerine pill/patch/paste, isordil and imdur -

Keywords: exercise stress test
azilsartan/amlodipine combination tablets ld & hd specified drug-use survey "long-term use survey"

Conditions: Hypertension

Summary: the purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets low dose (ld) \& high dose (hd) (zacras combination tablets ld \& hd) in hypertensive patients in daily medical practice.

this survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets ld \& hd (zacras combination tablets ld \& hd) in hypertensive patients in daily medical practice. for adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg \[for ld tablets\] or 20 mg/5 mg \[for hd tablets\] of azilsartan/amlodipine) is administered orally once daily. azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.

Eligibility criteria:
inclusion criteria: -hypertensive patients exclusion criteria: -hypertensive patients who meet any of the following conditions, \[1\] to \[3\], are excluded from the survey: 1. patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs 2. patients who are pregnant or having possibilities of being pregnant 3. diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

Keywords: pharmacological therapy
confidenht system for diagnostic electrical mapping of renal nerves

Conditions: Hypertension

Summary: to evaluate the safety and performance of the confidenht system

to evaluate the safety and performance of the confidenht system for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. age \>18 years and \<75. 3. either: 1. hypertensive patients planned to undergo elective cardiac catheterization 2. potential candidates for renal sympathetic denervation 4. main renal artery with diameter ≥ 4.0mm. 5. glomerular filtration rate (gfr) \>45 ml/min 6. a patient who is mentally competent with the ability to understand and comply with the requirements of the study. 7. the patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests. 8. female patients with childbearing potential must agree: * to use a valid method of contraception (oral contraceptives, intrauterine device, subcutaneous contraceptive implant, vaginal ring) * to perform a pregnancy test exclusion criteria: 1. previous participation in another study with any investigational drug or device within the past 30 days. 2. relevant renal artery disease (% diameter stenosis\>30%, aneurysm or fibromuscular dysplasia). 3. known secondary causes of hypertension. 4. the patient has a life expectancy ≤ 12 months. 5. the patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts. 6. the patient has chronic oxygen use other than nocturnal support for sleep apnea. 7. the patient has type i diabetes mellitus. 8. the patient has had a previous organ transplant or is awaiting a renal transplant. 9. active implantable medical device (e.g. icd or crt-d; neuromodulator/spinal stimulator; baroreflex stimulator). 10. the patient has triple ipsilateral artery ostia. 11. moderate to severe valvular heart disease. 12. the patient has other concomitant conditions that may adversely affect the patient or the study outcome. 13. female who is pregnant, nursing or planning to become pregnant. 14. documented contraindication or allergy to contrast medium not amenable to treatment.

Keywords: rdn
analysis of volatile organic compounds in patients with type 1 diabetes in induced hypoglycaemia with a breath analyser

Conditions: Diabetes Mellitus; Metabolic Disease; Glucose Metabolism Disorders; Endocrine System Diseases

Summary: the breath analysis (breathspec® device) data of all participants that were included into the vaara study (nct05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. the primary objective is to find a possible association between volatile organic compounds (vocs) measured by the breathspec® device and blood glucose. for this we will use descriptive statistics, correlation coefficients, as well as a principal component analysis and a partial least squares discriminant analysis. furthermore, the time lag between hypoglycaemia onset and change in vocs will be quantified.


Eligibility criteria:
(as in vaara study, nct05771090) inclusion criteria: * written informed consent. * type 1 diabetes with multiple daily insulin injection (mdi) or continuous subcutaneous insulin infusion therapy (csii) \>1 year * age 18 - 50 (inclusive) * caucasian ethnicity * bmi between 18.5 and 24.9 kg/m2 (inclusive) * usage of a continuous glucose monitoring (cgm) exclusion criteria: * pregnancy or lactation period * history of cardiovascular diseases * diabetes-related comorbidities * hba1c \>9 % * epilepsy * smoking (last cigarette within past 6 months) * known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome. * known sensitivity to latex. * participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.

Keywords: volatile organic compounds hypoglycaemia
postoperative pain control after kidney surgery : a comparison of intrathecal morphine plus pca and pca only

Conditions: Postoperative Pain

Summary: postoperative pain after kidney surgery is very high. we always use pca for postopertive pain. but almost patients still had severe pain. we try to use spinal morphine before operation aims to reduce pain.


Eligibility criteria:
inclusion criteria: * kidney surgery who less than 60 years old. * no underlying disease * asa less than 3 exclusion criteria: * refuse spinal morphine * history of morphine allery

Keywords: patient who recieve kidney surgery and patient controlled anesthesia with spinal morphine, intrathecal
sleep apnea in acromegaly after surgery

Conditions: Sleep Apnea

Summary: sleep apnea is common in acromegaly and both diseases are independently associated with hypertension and insulin resistance contributing to increased morbidity and mortality. respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea. the aim of this study is to evaluate the prevalence of sleep apnea by respiratory polygraphy, and to analyze the effect of transsphenoidal surgery on sleep apnea.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed acromegaly exclusion criteria: * patients who can not undergo transsphenoidal surgery

Keywords: sleep apnea acromegaly transsphenoidal surgery respiratory polygraphy
modified method of eversion carotid endarterectomy in patients with extensive atherosclerotic disease of carotid bifurcation

Conditions: Carotid Stenosis; Carotid Artery Diseases

Summary: a prospective comparative randomized single-centre non-inferiority trial. the purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

introduction. performing eversion endarterectomy some difficulties arise. firstly, it requires a great deal of coherence between the work of the surgeon and the first assistant, as well as a great experience of the latter. secondly, in some cases, there are difficulties in visualizing the distal margin of the intima: in the absence of a rigid skeleton, the soft unchanged artery walls after removal of the plaque subside, making it difficult to visualize possible fragments of the intima. thirdly, the cost of the error is high: with a random de-version, repeated eversion turns out to be impossible. it should be noted that the use of an eversion technique becomes difficult to implement, and sometimes impossible, with extended stenosis, since a very high allocation of the ica is required, which increases the invasiveness of the operation and the difficulty of access. with prolonged stenosis, the carotid endarterectomy remains the option of choice. the modification used eversion carotid endarterectomy combines the advantages of both methods, and also eliminates the limitations of the carotid endarterectomy and eversion carotid endarterectomy. the aim of study. the purpose of this study is to compares of modified method of eversion carotid endarterectomy with standard eversion carotid endarterectomy for 3,6 and 12 months days after operation in patients with extensive atherosclerotic disease of carotid bifurcation

Eligibility criteria:
inclusion criteria: * patients with stenosis of ica 70-99% (ultrasound - nascet and ct angiography) * patients with a extensive lesion of the ica (plaque \< 2 cm) by ultrasound - nascet and ct angiography exclusion criteria: * patients with a extensive lesion of the ica (plaque \< 2 cm), * patients with a contralateral occlusion of the ica * patients with stroke in ischemic type in the acute period.

Keywords: carotid endarterectomy eversion carotid endarterectomy prophylaxis of ischemic stroke carotid arteriosclerosis carotid artery plasty
late organ specific adverse effects hipec or pelvic exenteration

Conditions: Colorectal Cancer

Summary: the purpose of this study is to describe type and extent of organ specific late adverse effects in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.

after being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on bowel function, urinary function, pain, sexual function and lymphedema. all these aspects will be investigated using validated questionnaires.

Eligibility criteria:
inclusion criteria: * patients who have undergone intended curative crs+hipec for peritoneal metastases originated from colorectal cancer (hipec cohort) according to national danish guidelines * patients who have undergone intended curative total or anterior pelvic exenteration (pe cohort) for advanced or recurrent colorectal cancer according to national danish guidelines exclusion criteria: * patients under 18 years * patients not speaking danish or swedish, respectively, in denmark and sweden * patients unable to give informed consent * patients undergoing crs+hipec or pe for cancers others than crc * terminally ill patients

Keywords: cytoreductive surgery hyperthermic intraperitoneal chemotherapy pelvic exenteration adverse effects bowel dysfunction urinary dysfunction sexual dysfunction pain lymphedema
visual function evaluation of bilateral acrysof restor aspheric iol

Conditions: Cataracts

Summary: the objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the restor aspheric intraocular lens (iol).


Eligibility criteria:
inclusion criteria: * bilateral cataract patients who require natural crystalline lens removal and bilateral intraocular lens (iol) implantation. * 50\~75 years of age * \<1 diopter of astigmatism preoperatively (before surgery) as measured by keratometry readings. exclusion criteria: * patients with pre-existing conditions that could skew the results. * any of conditions before and during surgery specified in the product information.

Keywords: cataract visual acuity acrysof restor aspheric intraoculare lens bilateral cataract
safety and efficacy assessment of the zlock facet fusion system- a pilot study

Conditions: Low Back Pain

Summary: zygofix has developed a system consisting of zlock facet fusion system. the zlock facet fusion system is intended for single level stabilization of a spinal motion segment to promote bonny fusion of the joint. the system is designed for percutaneous deployment. the zlock implant is designed to be deployed in the facet joint thereby utilizing the body's natural mechanical structure without adding an external scaffold (see figure below). the zlock implant is inserted into the facet joint space while it adapts to the joint's changing geometry. stabilization is achieved by firm grip of each joint bone and resisting to any relative motion. the zlock implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness, procedure duration and shorten the recovery period. this pilot study was designed in order to assess the safety and effectiveness of the zlock system.


Eligibility criteria:
inclusion criteria: 1. patient is scheduled for spine surgery with at least one of the following: when used in adjunct to an intervertebral front cage: * degenerative spondylolisthesis up to grade 2 * mild to moderate degenerative disc disease (ddd) * degeneration of the facets - following validating the pain source by facet injection. when used stand-alone: * degenerative spondylolisthesis grade 1-2 * moderate to severe stenosis with listhesis * moderate to severe stenosis without listhesis (in cases that the investigator determines stabilization is required). * degeneration of the facets- following validating the pain source by facet injection. 2. claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging. 3. 18\< age \< 75 4. weight \< 100kg 5. signed informed consent form 6. at least 3 months of unsuccessful conventional treatments exclusion criteria: 1. fusion procedure performed or required in more than one inter-vertebrae space. 2. active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. 3. osteoporosis 4. absence of posterior spinal elements including the pedicle, pars interarticularis, facet joints, spinous process and the majority of the lamina which make it unstable or not possible to place. 5. any entity or conditions that totally preclude the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia, are relative contraindications. 6. obesity (bmi ≥30) 7. foreign body sensitivity 8. alcoholism, or drug abuse 9. subject with a cardiac pacemaker or other implanted electro medical device 10. subject with known condition of drug abuse and/or alcoholism 11. women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception) 12. concurrent participation in another clinical trial using any investigational drug or device. 13. mental disorders.

Keywords: stabilization, facet arthritis, spondylolisthesis, stenosis
assessment of the safety and efficacy of bg9924 in rheumatoid arthritis (ra) participants

Conditions: Rheumatoid Arthritis

Summary: safety and efficacy of bg9924 in ra participants that have had an inadequate response to disease-modifying anti-rheumatic drug (dmard) therapy.


Eligibility criteria:
key inclusion criteria: * diagnosis of ra (functional class i - iii) * stable dose of mtx * inadequate response to at least one conventional dmard therapy key exclusion criteria: * serious local infection or systemic infection * history (hx) of recurrent infections requiring oral or parenteral anti-infective treatment * hx of tuberculosis (tb) or positive purified protein derivative (ppd) test during the screening period * clinical significant lab tests at screening * positive for hep c or hep b at screening note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: rheumatoid arthritis ra dmard inadequate response methotrexate